Sr. R&D Engineer (Process Development) - Shockwave

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr R&D Engineer (Process Development) – Shockwave to join our team located in Santa Clara, CA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr. R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Sr. R&D Engineer will act as the subject matter expert for the engineering team, provide oversight to pilot manufacturing/testing, and see products transition from development into full production. This position will participate on multiple cross-functional development teams that focus on process optimization, sustaining, and design support.  The Sr. R&D Engineer will develop, validate, and implement various processes by working closely with research/development, operations, regulatory, and quality teams.

Essential Job Functions

• Develop product(s) for manufacturing in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDR requirements
• Prototype and develop designs, processes, and test methods in support of new product designs scaling for commercialization
• Represents R&D as a primary point of contact on manufacturing-related project activities, including internal and external requests.
• Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation
• Participate on cross-functional development team that manage projects from concept through commercialization
• Responsible for ensuring proper documentation consistent with company’s quality system
• Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives
• Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP
• Develop protocols/reports and perform product verification and validation testing
• Perform process-related design tasks to support pilot manufacturing
• Identify suppliers and maintain relationships to ensure the delivery of superior components and services
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products
• Responsible for component and assembly documentation for new products being developed
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations
• Other duties as assigned

Requirements

• Bachelor’s degree in Mechanical or Biomedical Engineering with 5 years’ experience in engineering or a master’s degree with 3 years’ experience in engineering
• Engineering experience in the medical device industry is highly preferred
• Knowledge of disposable peripheral and coronary device design, material selection, and testing
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
• Experience in early-stage catheter based cardiovascular devices development is a strong plus
• Effective communication skills with all levels of management and organizations
• Ability to work